The European Medicines Agency expects platform trials to play a bigger role in supporting marketing authorization ...

NRx Pharmaceuticals has received a discipline review letter from the US Food and Drug Administration requesting "minor” ...

FDA approval of a new adalimumab manufacturing process and a second drug substance suite in Reykjavik will more than double ...

CAR-T sales are forecast to nearly double by 2032 but sustaining that growth will hinge on earlier-line adoption, next-gen ...

Danaher says it wants to foster more connections between its operating companies across diagnostics and life sciences.

NIH nutrition research and dietary supplement chief Andrew Bremer says providing nutritionals for consumers receiving drug ...

Speakers at the DIA Real World Evidence conference urged sponsors and researchers to share clinical trial failures and ...

In an Oct. 20 interview, NAD attorney Laura Protzmann said a beauty brand’s exposure for what a chatbot says turns on how ...

CMS' approach to defining bona fide fees' fair market value "largely aligns" with 2026 Medicare Physician Fee Schedule proposed rule.

With positive Phase II data for its oral biologic cocktail in curing and preventing recurrence of CDI, Lumen hopes to find a deep-pocketed partner to help fund a larger Phase III study.

In an interview with the Pink Sheet, de Claro said he plans to continue refining programs on review efficiency and innovation, regulatory science, and external engagement, and said the speedy review ...

As the CLARITY trials hit primary and key secondary endpoints, execs from Roivant subsidiary Priovant dug into how the non-infectious uveitis (NIU) treatment landscape has evolved.